Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Effects of LY3372689 on the Brain in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03944031
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3372689 Diagnostic Test: [18F]LSN3316612 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 22, 2019
Estimated Study Completion Date : November 22, 2019

Arm Intervention/treatment
Experimental: LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
Drug: LY3372689
Administered orally.

Diagnostic Test: [18F]LSN3316612
Administered IV.
Other Name: [18F]MNI-1068




Primary Outcome Measures :
  1. Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO) [ Time Frame: Predose Scan (Days -14 to -1) ]
    Percent OGA EO

  2. Percent OGA EO [ Time Frame: Postdose Scan 1 (Days 1 - 4) ]
    Percent OGA EO

  3. Percent OGA EO [ Time Frame: Postdose Scan 2 (Days 2 - 4) ]
    Percent OGA EO



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy males or females who cannot get pregnant
  • Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
  • Have veins and arteries suitable for protocol required blood sampling

Exclusion Criteria:

  • Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
  • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
  • Have long exposure to sunlight routinely or use tanning beds regularly
  • Participate in regular vigorous exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944031


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Layout table for location information
United States, Connecticut
Institute for Neurodegenerative Disorders Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact    203-401-4346      
Principal Investigator: David S Russell         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03944031     History of Changes
Other Study ID Numbers: 17220
I9X-MC-MTAB ( Other Identifier: Eli Lilly and Company )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes